Pristine Scope

FDA 510(k) K183165 · Pristine Surgical

Substantially Equivalent

510(k) numberK183165

Submission

Device name
Pristine Scope
Applicant
Pristine Surgical
Manchester, NH, US
Received
November 15, 2018
Decision date
January 16, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HRX – Arthroscope
Device class
Class II (moderate risk)
Regulation
21 CFR 888.1100
Specialty
Orthopedic

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other 510(k)s with product code HRX

510(k)DeviceApplicantDecision
K260203Fule Vertebroplasty Balloon CatheterHRX · Traditional Beijing Fule Science & Technology Development…08/28/2026SE
K254103HOPKINS Telescopes for ArthroscopyHRX · Traditional Karl Storz SE & CO. KG08/26/2026SE
K252790Digital ClarusScope System and Digital NeuroPEN SystemHRX · Traditional Clarus Medical, LLC05/26/2026SE
K253523Freedom DS™ Decompression SystemHRX · Traditional Spinal Simplicity04/16/2026SE
K252546VantageTM Lumbar Decompression KitHRX · Traditional Allevion Medical, LLC03/12/2026SE
K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500)…HRX · Traditional Medimaging Integrated Solution, Inc (Miis)12/23/2025SE
K250795Purevue™ FMSHRX · Traditional W.O.M. World of Medicine GmbH12/05/2025SE
K252666Articulator Arthroscopic BurHRX · Traditional Joint Preservation Innovations, LLC11/21/2025SE
K252458Kyphoplasty Balloon Dilatation CathetersHRX · Traditional Shanghai Lange Medtech Co., Ltd.11/03/2025SE
K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHRX · Traditional Hand Biomechanics Lab, Inc.10/15/2025SE

More from Hand Biomechanics Lab, Inc.

510(k)DeviceDecision
K223244Pristine Arthroscopic Visualization SystemHRX · Special 12/21/2022SE
K193161Pristine ScopeGCJ · Traditional 04/21/2020SE

Questions and answers

When was Pristine Scope cleared by the FDA?

Pristine Scope (K183165) received a 510(k) decision of Substantially Equivalent on January 16, 2019, 62 days after the submission was received.

What is the product code of K183165?

The FDA product code is HRX – Arthroscope, a Class II (moderate risk) device regulated under 21 CFR 888.1100.